Medication Adherence Telemonitoring to Reduce Heart Failure Readmissions



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:1/24/2018
Start Date:December 2014
End Date:November 2015

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Telemonitoring Adherence to Medications to Reduce Heart Failure Readmissions: A Pilot Randomized Clinical Trial

The overall purpose of this project is to determine the feasibility of conducting a large
scale randomized clinical trial that compares remote monitoring of adherence to loop
diuretics using a wireless electronic pillcap with usual care among recently hospitalized
heart failure patients. The long-term goal of this program of research is to determine the
effect of the adherence telemonitoring intervention on medication adherence and hospital
readmissions among recently hospitalized heart failure patients.

Approximately one in four patients hospitalized with heart failure is readmitted within 30
days of discharge and more than 50% are readmitted within 6 months of discharge. Heart
failure admissions are a major contributor to the enormous health care costs associated with
heart failure. Thus far, the identification of effective interventions that prevent
unnecessary readmissions has remained elusive. As a result, there is a pressing need to
identify novel, cost-effective approaches to reducing heart failure readmissions. A growing
body of research suggests that poor adherence to heart failure medications is a major reason
for preventable heart failure readmissions. In particular, loop diuretic medications are
essential to preventing the cardiopulmonary system from becoming overloaded. Patients who
have been recently hospitalized may be especially vulnerable to adherence problems as a
result of the stress of the recent hospitalization which commonly induces sleep deprivation,
nutritional deficiency, physical deconditioning, cognitive impairment, and even delirium.
Recent advances in wireless health now enable us to remotely, unobtrusively, and objectively
monitor adherence to heart failure medications in the post-discharge period. Early
identification of non-adherence to loop diuretic medications has the prevention to prevent a
volume overloaded state that leads to a heart failure readmission. As patients who are
non-adherent to their loop diuretics may also be non-adherent to other recommended
self-management behaviors, early identification of medication nonadherence may provide the
context to identify other gaps in self-management. To test our hypothesis that it is feasible
to conduct a randomized trial of wireless, medication adherence monitoring with feedback to
patients and clinicians, the investigators will enroll 40 patients who are hospitalized for
heart failure and discharged on a diuretic medication. Patients will be randomized to 1)
usual heart failure care + telemonitoring adherence to diuretic medications (INT); N=20 or 2)
usual heart failure care (CTR); N=20. All patients will be asked to take their diuretic
medication from a standard pill bottle covered by an electronic pill cap (GlowCap), but only
patients assigned to the intervention arm will have their adherence telemonitored by a study
clinician in real-time. Patients will have their adherence to medications measured in this
fashion for 30 days after discharge. Patients will be contacted at 30 days to determine if
they have been hospitalized and to collect other self-reported outcomes data.

Inclusion Criteria:

- Hospitalized for heart failure

- Prescribed loop diuretic medication at discharge

Exclusion Criteria:

- Age less than 21 years

- New York Heart Association Class IV heart failure

- Terminal illness (<6 mo prognosis)

- Unable to self-administer medications due to mental illness or cognitive impairment

- Non-English/Spanish speaking

- Discharged to an institutional setting (e.g., nursing home)

- Cardiologist or primary care provider refusal

- Unavailable for follow-up

- No access to telephone

- Enrolled in another cardiac trial
We found this trial at
1
site
630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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mi
from
New York, NY
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